ASTM F1886/F1886M-16: TMV Visual Inspection

Start here: Before you start validating test methods (TMV), please read through our written guide. Here we summarize the theory you need to know about TMV in a nutshell. The following content awaits you: 

- Basics: Test Methods 

- Basics: Test Method Validation

- Regulatory & Normative Requirements 

- How to prepare for your TMV. 

- Checklist: Compliant Test Method Validation

Watch the video to learn how to fill out the TMV Protocol template correctly. Use the TMV Protocol template and adjust it according to your needs.

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In this video, we walk you through the ASTM F1886/1886M-16 Standard Test Method Assessment Form for Visual Inspection. Simon explains how to complete the document to create compliant documentation. If you have any specific questions about this video, please contact us at office@sifo-medical.com . office@sifo-medical.com.

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Learn how to organize your raw data (attribute data) in Excel. In this example we use 3 operators (A, B, C) who each check 15 parts and perform 2 trials, i.e. we have 90 assessments. Watch the video to learn how to organize your data.

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Learn how to analyze your data in Minitab. In the case of visual inspection, we perform an Attribute Agreement Analysis in Minitab.

We record the results of our analysis in the TMV report. Watch the video to learn how to complete the TMV report template correctly.

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Use a decision tree to prove the intended purpose of your test method.

Use this checklist to ensure your test method validation complies with all relevant MedTech regulations and standards.

Use this checklist to ensure that you do not forget any important steps when validating your test methods.